FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
163825–163848 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 14, 1981
EXMOOR AURAL GROMMET AG/T3
K810704 · ETD
Exmoor Plastics , Ltd.
Ear, Nose, Throat · 29d
Cleared Apr 14, 1981
EXMOOR AURAL GROMMET AG/T4
K810705 · ETD
Exmoor Plastics , Ltd.
Ear, Nose, Throat · 29d
Cleared Apr 14, 1981
EXMOOR AURAL GROMMET AG/T5
K810706 · ETD
Exmoor Plastics , Ltd.
Ear, Nose, Throat · 29d
Cleared Apr 14, 1981
HARRIS HEMATOXYLIN
K810733 · HYK
Surgipath
Pathology · 27d
Cleared Apr 14, 1981
GILL'S HEMATOXYLIN #1
K810758 · HYJ
Surgipath
Pathology · 25d
Cleared Apr 14, 1981
GILL'S HEMATOXYLIN #2
K810759 · HYJ
Surgipath
Pathology · 25d
Cleared Apr 14, 1981
GILL'S HEMATOXYLIN #3
K810760
Surgipath
Pathology · 25d
Cleared Apr 14, 1981
GDC-1054
K810789 · EJT
Deringer-Ney, Inc.
Dental · 22d
Cleared Apr 14, 1981
LOW DOSE SERVOCHEST
K810797 · KPR
Philips Medical Systems (Cleveland),...
Radiology · 22d
Cleared Apr 14, 1981
WATER PIK AUTOMATIC TOOTHBRUSH
K810805 · JEQ
Teledyne, Inc.
Dental · 21d
Cleared Apr 14, 1981
DMG-POLISHABLE COMPOSITE
K810813 · EBD
Dental-Material Gesellschaft
Dental · 21d
Cleared Apr 14, 1981
MEDI/NUCLEAR #XE-102 XENON/MASTER
K810819 · IYT
Medi Nuclear Corp., Inc.
Radiology · 21d
Cleared Apr 14, 1981
POLYVINYL SILICONE IMPRESSION MATERIAL
K810825 · ELW
Dental-Material Gesellschaft
Dental · 21d
Cleared Apr 14, 1981
HOYT COTTON ROLLS
K810830 · EFN
Hoyt Laboratories
Dental · 20d
Cleared Apr 14, 1981
CREATINE KINASE MB ISOENZYME IMMUNO UV
K810861 · JHW
The Dow Chemical Co.
Chemistry · 14d
Cleared Apr 14, 1981
KALLESTAD HEP-2 CELL LINE SUBSTRATE
K810863 · DBM
Kallestad Laboratories, Inc.
Immunology · 14d
Cleared Apr 14, 1981
FOLLICLE STIMULATING HORMONE (FSH)
K810867 · JIS
Pcl-Ria, Inc.
Chemistry · 14d
Cleared Apr 14, 1981
GEMENI CK-MB ISOENZYME ABNORMAL SERUM
K810870 · JJT
Gemini, Inc.
Chemistry · 14d
Cleared Apr 14, 1981
COAT-A-COUNT CORTISOL RIA KIT
K810891 · CGR
Diagnostic Products Corp.
Chemistry · 12d
Cleared Apr 14, 1981
INSULATIVE COATING FOR CARD. PULSE GEN
K810901 · DXY
Intermedics, Inc.
Cardiovascular · 11d
Cleared Apr 14, 1981
NEWBORN BOVINE SERUM
K810903 · KIS
Biolabs, Inc.
Pathology · 11d
Cleared Apr 14, 1981
BOVINE CALF SERUM
K810904 · KIS
Biolabs, Inc.
Pathology · 11d
Cleared Apr 14, 1981
ISOMUNE-CK
K810905 · JHW
Hoffmann-La Roche, Inc.
Chemistry · 11d
Cleared Apr 14, 1981
TRI-LEVEL NDI CONTROL
K810906 · JJY
Nuclear Diagnostics, Inc.
Chemistry · 11d